BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE - ORAL

BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE - ORAL

PHONETIC PRONUNCIATION: (BIZ-muth sub-SIT-rate/MET-roe-NYE-da-zole/TET-ra-SYE-kleen)

COMMON BRAND NAME(S): Pylera

GENERIC NAME(S): colloidal bismuth subcitrate/metronidazole/tetracycline HCl

Uses

USES: This combination medication is used with an acid blocker (e.g., a proton pump inhibitor such as omeprazole). It is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Each capsule contains 3 medications: bismuth subcitrate, metronidazole, and tetracycline. Bismuth subcitrate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria. Metronidazole and tetracycline are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria. This product treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This product is not recommended for use in children.


How to use BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE - ORAL

HOW TO USE: Take this medication by mouth 4 times daily (after meals and at bedtime) for 10 days. Take each dose (3 capsules) with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Swallow the capsules whole. Do not crush or chew the capsules. Do not lie down for at least 10 minutes after taking this medication. Follow your doctor's instructions on how to correctly take an acid blocker with this medication. Take this medication 2 to 3 hours before or after taking any products containing magnesium, aluminum, or calcium. These products bind with tetracycline, preventing its full absorption. Some examples include quinapril, certain forms of didanosine (e.g., chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and antacids. Dairy products (e.g., milk, yogurt), calcium-enriched juice, sucralfate, iron, and zinc are also included. Take this medication regularly in order to get the most benefit from it. Continue to take this medication and the acid blocker until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection/ulcer. Tell your doctor if your condition persists or worsens.

Side Effects

SIDE EFFECTS: Nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Your tongue may turn dark in color while you are taking this medication. This is harmless, and the effect will disappear when you stop the medication. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, discolored teeth, mental/mood changes (such as confusion, anxiety, irritability, depression), difficult/painful swallowing, heartburn, fast/pounding heartbeat, ringing in the ears, frequent/painful urination. Tell your doctor right away if any of these rare but very serious side effects occur: severe headache, stiff/painful neck, signs of kidney problems (such as change in the amount of urine), signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual weakness/tiredness, seizures, chest pain, symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine). This product commonly causes dark stools that are usually not serious. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a serious condition. Therefore, tell your doctor right away if you have dark stools. Tetracycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tetracycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: persistent/severe headache, vision changes (such as blurred/double vision, decreased vision, sudden blindness), persistent nausea/vomiting. This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea or opioid medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool. Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Side Effects section. Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subcitrate, metronidazole, or tetracycline; or to tinidazole; or to other tetracyclines (e.g., doxycycline); or to other bismuth products (e.g., bismuth subsalicylate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood disorders, brain/spinal cord disorders (e.g., seizures), trouble swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), a certain rare genetic disorder (Cockayne syndrome). Antibiotics may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to. Before having surgery, tell your doctor or dentist that you are using this product. Tetracycline may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Avoid alcoholic beverages and products containing propylene glycol while taking this product and for at least 3 days after finishing this product because severe stomach upset/cramps, nausea, vomiting, headache, and flushing may occur. This product may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. Children should not take this product because it contains tetracycline. Tetracycline may cause permanent tooth discoloration and other problems in children younger than 8 years. Tooth discoloration has also occurred in older children and young adults. Consult the doctor for more information. This product must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. This product contains drugs that may pass into breast milk. Discuss the risks and benefits with your doctor before breast-feeding. Consult your doctor for more details.

Interactions

DRUG INTERACTIONS: See also Precautions section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: retinoid medications (such as acitretin, isotretinoin, tretinoin), strontium, alcohol-containing products (such as cough and cold syrups, aftershave), products containing propylene glycol, atovaquone, digoxin, lithium, lopinavir/ritonavir solution. Do not take this product if you are also taking disulfiram or if you have taken disulfiram within the last 2 weeks. Although most antibiotics (including metronidazole and tetracycline) are unlikely to affect hormonal birth control such as pills, patch, or ring, a few antibiotics (such as rifampin, rifabutin) can decrease their effectiveness. This could result in pregnancy. If you use hormonal birth control, ask your doctor or pharmacist for more details. This product may interfere with certain lab tests, possibly causing false test results. This product may also interfere with X-ray exams of the stomach/intestines. Make sure lab personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures.

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Faq for BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE - ORAL

Bismuth Subcitrate/Metronidazole/Tetracycline is an oral medication used to treat a specific type of stomach infection called Helicobacter pylori (H. pylori). It is often prescribed in combination with other antibiotics.

The combination of Bismuth Subcitrate, Metronidazole, and Tetracycline works by killing the H. pylori bacteria. Bismuth subcitrate suppresses the growth of bacteria, while Metronidazole and Tetracycline specifically target and destroy the bacteria.

Common side effects may include stomach upset, diarrhea, nausea, vomiting, metallic taste in the mouth, dark-colored stools, or changes in tongue color. Some people may also experience an allergic reaction, such as rash or itching.

It is usually recommended to take this medication with food, as it helps reduce stomach upset. Follow the dosage instructions provided by your doctor and complete the full course of treatment. Do not skip doses or stop taking it prematurely, even if you start feeling better.

It is generally not recommended to take this medication during pregnancy, especially during the first trimester. Consult your doctor for alternative treatment options. If you are breastfeeding, it is best to avoid this medication as it may pass into breast milk.

Inform your doctor about all the medications, supplements, or herbal products you are currently taking, as they may interact with Bismuth Subcitrate/Metronidazole/Tetracycline. Some medications, such as antacids, may reduce the effectiveness of this medication. Also, avoid consuming alcohol while taking this medication, as it can lead to severe side effects.

Tell your doctor if you have any underlying medical conditions, such as kidney or liver disease, or if you are allergic to any of the ingredients in this medication. Also, let your doctor know about any ongoing or past antibiotic usage to ensure safe and effective treatment.

The duration of treatment varies, but it generally lasts for about 7 to 14 days. Always complete the full course of treatment, even if your symptoms improve before the prescribed duration.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

The dosage may vary depending on the severity of the infection, but a common dosage is taking four capsules four times a day, after meals and at bedtime, for a period of 14 days.

Yes, there are potential side effects such as nausea, vomiting, diarrhea, metallic taste in the mouth, dark stools, and a temporary black discoloration of the tongue. Rarely, it may cause serious side effects like liver problems or an allergic reaction.

Yes, Bismuth Subcitrate/Metronidazole/Tetracycline can interact with several medications, including anticoagulants, antacids, and certain antibiotics. It is important to inform your healthcare provider about all the medications you are taking to avoid potential interactions.

It is not recommended to take this medication during pregnancy or while breastfeeding, unless specifically prescribed by a healthcare professional. It is important to discuss the potential risks and benefits with your doctor.

The medication starts working within a few days, but it is essential to complete the full course of treatment as prescribed by your doctor, even if symptoms improve.

It is recommended to take Bismuth Subcitrate/Metronidazole/Tetracycline after meals to reduce the risk of stomach upset. However, it is crucial to follow the specific instructions provided by your healthcare provider.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.